הצגת המקור של תבנית:תרופה/קיטרודה 100 מ"ג/4 מ"ל - Keytruda 100 mg/4 ml

{{תרופה
|שם בעברית={{{שם בעברית|קיטרודה 100 מ"ג/4 מ"ל}}}
|שם באנגלית={{{שם באנגלית|Keytruda 100 mg/4 ml}}}
|מרכיב פעיל={{רווח קשיח}}
*[[Pembrolizumab]] 100MG / 4 ML {{כ}}[[L01XC18]]
|קבוצה פרמקולוגית (ATC)={{ATC משרד הבריאות|L01XC|Monoclonal antibodies}}
|צורת מתן=תוך-ורידי - I.V
|צורת מינון=תרכיז להכנת תמיסה לאינפוזיה, CONCENTRATE FOR SOLUTION FOR INFUSION{{ש}}למניעת מינון יתר או הרעלה יש ליטול את התרופה בהתאם למינון המומלץ כפי שמופיע בעלון לצרכן
|סל הבריאות=כלול בסל
|במרשם=כן
|התוויה=
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Melanoma• KEYTRUDA is indicated for the treatment of adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma.•KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection.Non-Small Cell Lung Cancer• KEYTRUDA, in combination with pemetrexed and carboplatin, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) negative for EGFR or ALK genomic tumor aberrations.• KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound , is indicated for the first-line treatment of patients with metastatic squamous NSCLC.• KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 [Tumor Proportion Score (TPS) ≥50%)] as determined by a validated test. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on or after platinum-containing chemotherapy and an approved therapy for these aberrations prior to receiving KEYTRUDA .• KEYTRUDA, as a single agent, is indicated for the treatment of patients with advanced NSCLC whose tumors express PD-L1 as determined by a validated test, with disease progression on or after platinum containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on approved therapy for these aberrations prior to receiving KEYTRUDA .• KEYTRUDA , as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC.Head and Neck Cancer• KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).• KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test .• KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy..Classical Hodgkin Lymphoma• KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).• KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapyPrimary Mediastinal large B-Cell Lymphoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy.Limitation of Use: KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.Urothelial Carcinoma• KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [Combined Positive Score (CPS ≥10) ] as determined by a validated test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. • KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.Microsatellite Instability-High CancerKEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI H) or mismatch repair deficient (dMMR). • solid tumors that have progressed following prior systemic treatment and who have no satisfactory alternative treatment options,or• colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.Limitation of Use: The safety and effectiveness of KEYTRUDA in pediatric patients with MSI H central nervous system cancers have not been established. Gastric Cancer• KEYTRUDA, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 with a CPS ≥ 1.Cervical Cancer• KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by a validated test. • KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by a validated test.Biliary Tract CancerKEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC).Merkel Cell CarcinomaKEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).Renal Cell Carcinoma• KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).• KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC.• KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.Non-Muscle Invasive Bladder Cancer (NMIBC)KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.Esophageal Cancer• KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (Siewert type I) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy.• KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS ≥10) as determined by a validated test, with disease progression after one or more prior lines of systemic therapy.Cutaneous Squamous Cell CarcinomaKEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiationMicrosatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer (CRC)KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).Tumor Mutational Burden-High CancerKEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by a validated test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.Limitations of Use: The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.Triple Negative Breast Cancer• KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by a validated test• KEYTRUDA is indicated for the treatment of patients with high risk early stage triple negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.Endometrial carcinomaKeytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy and who are not candidates for curative surgery or radiation.
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|שם יצרן=[[MERCK SHARP & DOHME CORP., USA]]
|שם יצרן מקוצר=[[MERCK]]
|שם בעל הרישום=[[MERCK SHARP & DOHME ISRAEL LTD]]
|רישיון מתאריך={{{רישיון מתאריך|[[רישום מתאריך::09/2015]]}}}
|תאריך הגשה=03/2015
|קישור למאגר משרד הבריאות1=[https://israeldrugs.health.gov.il/#!/medDetails/154%2038%2034448%2000 קיטרודה 100 מ"ג/4 מ"ל] במאגר משרד הבריאות
|עלון לרופא={{רווח קשיח}}
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_14_119273824.pdf עלון לרופא 30.04.2024]
|עלון לצרכן={{רווח קשיח}}
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_14_119278824.pdf עלון לצרכן עברית 30.04.2024]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_14_119277324.pdf עלון לצרכן אנגלית - Patient information leaflet{{כ}} 30.04.2024]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_15_146409724.pdf עלון לצרכן ערבית - نشرة للمستهلك باللغة العربية 30.04.2024]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_6_1053135422.pdf חוברת מידע בטיחותי למטופל/הורי מטופל/מטפל עיקרי רב שפתי 28.12.2022]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_6_1053134122.pdf כרטיס מידע בטיחותי למטופלים רוסית 28.12.2022]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_2_190764522.pdf כרטיס מידע בטיחותי למטופלים ערבית 02.02.2022]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_2_190763722.pdf כרטיס מידע בטיחותי למטופלים אנגלית 02.02.2022]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_2_190761322.pdf כרטיס מידע בטיחותי למטופלים עברית 02.02.2022]
|החמרות לעלון={{רווח קשיח}}
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_14_119275924.pdf החמרה לעלון 30.04.2024]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_14_106415224.pdf החמרה לעלון 30.04.2024]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_14_100410124.pdf החמרה לעלון 31.03.2024]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_13_60056724.pdf החמרה לעלון 29.02.2024]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_13_45836624.pdf החמרה לעלון 29.02.2024]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_10_504926323.pdf החמרה לעלון 31.10.2023]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_10_286143623.pdf החמרה לעלון 30.09.2023]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_9_278914423.pdf החמרה לעלון 30.06.2023]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_6_990234422.pdf החמרה לעלון 25.10.2022]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_5_923691422.pdf החמרה לעלון 16.08.2022]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_5_911758222.pdf החמרה לעלון 16.08.2022]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_5_908280422.pdf החמרה לעלון 06.09.2022]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_3_711312122.pdf החמרה לעלון 14.04.2022]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_3_448936522.pdf החמרה לעלון 03.03.2022]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_2_265259322.pdf החמרה לעלון 29.12.2021]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_1_1331926921.pdf החמרה לעלון 17.11.2021]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_1_943499821.pdf החמרה לעלון 15.08.2021]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_1_937755821.pdf החמרה לעלון 14.09.2021]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_20_492561021.pdf החמרה לעלון לרופא 20.04.2021]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_19_390685421.pdf החמרה לעלון 21.03.2021]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_19_357692721.pdf החמרה לעלון 29.01.2021]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_16_341169020.pdf החמרה לעלון 19.08.2020]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_16_323532320.pdf החמרה לעלון 13.07.2020]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_15_237422620.pdf החמרה לעלון 29.02.2020]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_13_111804120.pdf החמרה לעלון 31.03.2019]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_8_92719018.pdf החמרה לעלון 11.07.2018]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_7_35290718.pdf החמרה לעלון לרופא 13.03.2018]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_5_114669517.pdf החמרה לעלון 29.10.2017]
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_4_42623917.pdf החמרה לעלון 25.04.2017]
|מספר רישום={{{מספר רישום|154 38 34448 00}}}
|תאריך עדכון=22/05/2024
|תמונת אריזה=https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_14_143293420.JPG
|שיווק הופסק=לא
|שם ללא מינון=קיטרודה - Keytruda
|שם ללא מינון באנגלית‎=Keytruda
|התאמת מינון=
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|ללא קטגוריה={{{ללא קטגוריה|<noinclude>-</noinclude>}}}
}}
<noinclude>{{תרופה/תיעוד}}</noinclude>